Director, Distinguished Engineer
Capital One
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Director – Chemistry Commercial Product Quality
Siemens Healthineers
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $172,690 - $259,030 per year
Job Level
Lead
About the role
- Responsible for leading the CLS Chemistry Commercial Product Quality (CPQ) Team responsible for complaint handling, medical device reporting and Field Action activities
- Develop and execute organizational strategies, processes, goals, and metrics that drive measurable improvements in complaint handling, product quality, and customer satisfaction
- Serve as a Subject Matter Expert for post market topics, processes and tools
- Ensure compliance with applicable regulations and standards
- Drive product safety, product quality, and customer satisfaction related decisions
- Establish short- and long-term goals to improve complaint resolution, product reliability, and customer satisfaction
- Report medical device reports on time
- Address FDA and other NCA concerns with product recalls
- Train and develop group members
- Drive continuous improvement and excellence in results for Key Performance Indicators (KPIs)
Requirements
- Typically, 8+ years of successful experience in related field
- Direct experience in the in-vitro diagnostics industry
- Strong knowledge in complaint handling, investigations, medical device reporting, field action and CAPA processes
- Detailed understanding of FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, MDSAP, and EU IVDR requirements
- Experience in Quality Systems, MDRs and Field Action recommended
- Advanced degree MAY be substituted for experience, where applicable
- Willing to travel 20%
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
complaint handlingmedical device reportingField ActionCAPA processesQuality SystemsMDRsKey Performance Indicators (KPIs)continuous improvementproduct reliabilityproduct quality
Soft skills
leadershiporganizational strategiescommunicationtraining and developmentstrategic planningproblem-solvingcustomer satisfaction focusteam collaborationdecision makinggoal setting
Certifications
ISO 13485MDSAPEU IVDR
